- Physicians Office Resource

CROSSER® CTO Recanalization Catheter 14S, Rapid Exchange, 146cm
CROSSER® - CRU14SA

Device Description

A sterile, flexible tube (catheter) intended to be percutaneously introduced for the intraluminal mechanical disruption of atheroma plaque from the walls of both coronary and peripheral arteries (or vein grafts). It has a power-driven cutting or abrasive head for slicing/grinding the atheroma into fragments small enough to be aspirated or absorbed. This is a single-use device.

Environmental Conditions

No Data Available

Device Sizes

Length: 146 Centimeter

Length: 146 Centimeter

Device Sterilization

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: PDU

Device Name: Catheter For Crossing Total Occlusions

Device Class: 2

Physical State: Peripheral catheter

Definition: To facilitate the intraluminal placement of conventional guidewires beyond stenotic lesions (including subchronic and chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention, such as angioplasty, atherectomy or stent placement.

Submission Type ID: 1

Review Panel: CV

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Creates narrow channel in occlusion to allow for guidewire placement for further percutaneous intervention, such as angioplasty, atherectomy or stent placement.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Peripheral vasculature

Regulation Number: 870.1250

Third Party Flag: N

Medical Specialty: CV

Device Identifiers

Device Id: 10801741125567

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A

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